JMIR Publications

ABSTRACT

Background:

Conventional clinical trials (CTs) are essential for generating high quality evidence by measuring efficacy of interventions in extremely controlled, clinical environments. However, their execution can be expensive and time consuming. In addition, CTs face several logistical challenges in the identification, recruitment and retention of participants, consistent data collection during trials, and adequate patient follow-up. This might lead to inefficient resource utilization. In order to partially address the current problems with conventional CTs, - there is a need for new innovative CTs. One of such innovative CTs is the Virtual Clinical Trial (VCT). VCTs allow for the collection and integration of diverse data from multiple information sources, such as electronic health records, clinical and demographic data, patient-reported outcomes, anthropometric and activity measurements, and data collected by digital biomarkers or (small) samples that participants can collect themselves. Although VCTs have the potential to provide huge value to clinical research and patients because they can lower clinical trial costs, increase the volume of data collected from patients’ daily environment, and reduce the burden of patient participation, VCT adoption is not commonplace as of yet.

Objective:

This paper aims to better understand the barriers and facilitators to the adoption of VCTs by determining the factors that influence individuals’ considerations regarding VCTs from the viewpoints of pharmaceutical organizations, food and health organizations and an applied research organization.

Methods:

A qualitative study was conducted by online semi-structured interviews with stakeholders in Europe. Sixteen individuals with interest and experience in VCTs were interviewed, including persons from pharmaceutical organizations (n=6), food and health organizations (n=4) and an applied research organization (n=6). Data were thematically analysed using Rogers’ diffusion of innovation theory.

Results:

Interviewees identified several barriers and facilitators. Key barriers entailed acceptance by regulatory authorities, technical issues (data interoperability/data storage), compliance and adherence and lack of knowledge/ understanding. Key facilitators consisted of involving regulators in development process, exposure to results of pilot studies and good instructions/assistance for patients.

Conclusions:

Collaborations among all stakeholders in VCT development is crucial to increase knowledge and awareness, organizations should invest in accurate data collection technologies and compliance of patients in VCTs needs to be ensured. It is suggested to conduct Multi-Criteria-Decision-Analysis which can explore if a VCT is a preferred option by stakeholders. The findings from this study can be a good starting point to accelerate the development and wide-spread implementation of VCTs.